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FDA Approval

LIDOTHOL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 8, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Menthol(5 g in 1 1)
Lidocaine(4.5 g in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIDOTHOL

Product Details

NDC Product Code
53225-1025
Route of Administration
TOPICAL
Effective Date
December 8, 2023
DITETRACYCLINE TETRASODIUM EDETATEInactive
Code: WX0A0IT7K5Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6Class: IACT
KAOLINInactive
Code: 24H4NWX5COClass: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)Inactive
Code: 99H65D77XYClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
.ALPHA.-ISOBUTYLPHENETHYL ALCOHOLInactive
Code: 2SBL0E1I0NClass: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341LClass: IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERInactive
Code: KFR5QEN0N9Class: IACT
MentholActive
Code: L7T10EIP3AClass: ACTIBQuantity: 5 g in 1 1
LidocaineActive
Code: 98PI200987Class: ACTIBQuantity: 4.5 g in 1 1
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